rivaroxaban anticoagulation for superficial vein thrombosis

Conditions: Symptomatic Superficial Vein Thrombosis

Summary: this is a phase iii, randomized, placebo controlled, blinded, parallel two arm, multicentre trial that will compare rivaroxaban 10mg daily with placebo in patients with symptomatic leg superficial vein thrombosis (\> or = 5cm) that otherwise would not initially be treated with anticoagulant therapy.

patients with symptomatic superficial leg thrombosis will be randomized into two arms, a) rivaroxaban 10mg 1 tablet daily for 45 days or b) placebo to determine if rivaroxaban (10 mg once daily) is an effective and safe treatment for superficial vein thrombosis.

Eligibility criteria:
inclusion criteria: - symptomatic superficial vein thrombosis of the leg of ≥5 cm length (diagnosed clinically or with ultrasound) exclusion criteria: * age \<18 years * symptoms \>42 days * receiving an anticoagulant for another indication (example: atrial fibrillation) when superficial vein thrombosis started. * superficial vein thrombosis already treated with more than 3 days of anticoagulation (example. fondaparinux or low molecular weight heparin). * planned treatment of superficial vein thrombosis with a course of anticoagulant therapy. * another indication for anticoagulant therapy (example. deep vein thrombosis, pulmonary embolism, atrial fibrillation). * judged to require immediate ligation of the saphenofemoral junction or stripping of thrombosed varicose veins. * proximal deep vein thrombosis or pulmonary embolism within the past 12 months. * superficial vein thrombosis associated with sclerotherapy or an intravenous canula. * a high risk of bleeding as evidenced by any of the following: 1. active bleeding 2. bleeding within the past 30 days due to a cause that has not fully resolved. 3. known or expected thrombocytopenia with a platelet count of less than 80,000 x 10 9/l. 4. history of ever having had spontaneous intracranial bleeding, or any intracranial bleeding within the past 3 months. 5. receiving dual antiplatelet therapy (example. aspirin and clopidogrel). * elevated creatinine level is suspected and creatinine clearance has not been estimated, or creatinine clearance (cockcroft-gault equation) of less than 30 ml/min. * clinically relevant hepatic disease (including child-pugh b and c) is known or suspected (example., associated with: international normalized ratio \>1.7; total bilirubin \>2 upper limit of normal; or alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>3 times upper limit of normal). * ongoing requirement for systemic treatment with azole-antimycotics (except fluconazole), human immunodeficiency virus (hiv) -protease inhibitors, or strong cytochrome p450 3a4 (cyp3a4) inducers due to the potential interaction with rivaroxaban. * pregnant or lactating women, or at risk of becoming pregnant. * life expectancy less than 90 days * patient is unwilling or unable to comply with the protocol (example. unable to attend follow-up visits because of geographic inaccessibility). * participating in a competing clinical investigation and receiving any other investigational agent(s).

Keywords: superficial vein thrombosis